Spots Global Cancer Trial Database for Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors
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Trial Identification
Brief Title: Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors
Official Title: A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors
Study ID: NCT05724108
Conditions
Study Description
Brief Summary: This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone.
Detailed Description: PRIMARY OBJECTIVE: I. Evaluate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of combination triapine + lutetium Lu 177 dotatate (treatment arm 1) versus standard of care lutetium Lu 177 dotatate alone (treatment arm 2). SECONDARY OBJECTIVE: I. Evaluate progression-free survival (PFS) between the two treatment arms (combination arm 1 versus standard of care arm 2). EXPLORATORY OBJECTIVES: I. Evaluate plasma hPG80 as a biomarker of treatment response. II. Evaluate plasma deoxyribonucleosides as a biomarker of triapine resistance. III. Collect plasma for circulating deoxyribonucleic acid (DNA) (ctDNA) assessment. IV. Evaluate triapine plasma pharmacokinetics (PK) in the combination arm (treatment arm 1 only). OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive triapine orally (PO) on days 1-14 of each cycle and lutetium Lu 177 dotatate intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. ARM 2: Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up at 8 and 12 months, then every 6 months for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
Ohio State University Comprehensive Cancer Center LAO, Columbus, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
MD Anderson in The Woodlands, Conroe, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson West Houston, Houston, Texas, United States
MD Anderson League City, League City, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Contact Details
Name: Lowell B Anthony
Affiliation: Ohio State University Comprehensive Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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